Verona Pharma plc (NASDAQ:VRNA) Q4 2022 Earnings Call Transcript

Those include ensuring that we’re covered under existing coverage policies, which we believe that will be the case with ensifentrine. We also are establishing and getting our paperwork ready for a product-specific J-code. That J-code submission will go in immediately upon approval. And then we should expect to get that product specific J-code within three to six months. In the meantime, you use the existing nonspecific J-code to get coverage and get payment to the pharmacies. So we feel very, very confident that ensifentrine coverage and overall ability to be used by the physicians is going to be high at launch and high throughout the first year. The other side of that story is what you discussed there is what copays for patients. And when we look at the Medicare Part B channel and Medicare in general, we see for the nebulized products over the last year is that 80% of these patients are paying less than $10 for their prescriptions of branded nebulized products.

This is an extremely attractive proposition for physicians. So not only do they get access, but they have low out-of pocket costs. So I think those dynamics allow us to be very excited about how we anticipate the uptake for ensifentrine to be when we launch in 2024.

Thomas Shrader: And may be just one quick clarification, you can talk to payers before approval or does everything start at approval?

Christopher Martin: We can have early discussions with payers before approval. Some of that is about the disease state and their needs, but we can have early discussions with payers as we move through the process.

Thomas Shrader: Great, thank you.

Christopher Martin: Thanks, Tom.

Operator: Our next question will come from Boobalan Pachaiyappan with H.C. Wainwright. You may now go ahead.

Boobalan Pachaiyappan: Hi, this is Boobalan. Can you hear me okay?

David Zaccardelli: Yes, perfectly.

Boobalan Pachaiyappan: All right, great. Good morning and thanks for taking our questions, few from us. So firstly, can you speak to how efficiently ensifentrine can be manufactured and expected COGS related to traditional LAMA and LABA therapeutics?

David Zaccardelli: Sure, I’ll make a general statement and Mark can comment on COGS. Anti-cancer small molecule and as manufacturing has been very well sorted over the years we believe we have an extremely efficient manufacturing process for the drug substance or ATI. The drug product is manufactured in the blow fill seal into plastic ampoules. Again, a process that’s very well described, and we’re very comfortable with the scale that has occurred. And I think the cost is, again in line with other products that are manufactured in the same way. I don’t know, Mark, do you want to comment?

Mark Hahn: Yes. I’ll just echo your comments, Dave, that it is a small molecule. So the cost of manufacturing, those are generally fairly consistent across compounds. And I think the way you should expect or think about COGS is low single-digit percentage of sales at least for manufacturing COGS.

Boobalan Pachaiyappan: All right, great. What will be the role of combination versus monotherapy for ensifentrine in your estimation?

David Zaccardelli: Well, I think, make sure I understand the question. Are you asking how often we would see it in combination or maybe to clarify your question specifically?

Boobalan Pachaiyappan: Yes, with respect to combination.